(43 days)
Visalys® Bulk Fill: Loss of tooth substance due to caries, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in deciduous teeth, core buildups, cavity floor elevation, repair of direct restorations after appropriate pretreatment and splinting / locking of teeth.
Visalys® Bulk Flow: Loss of tooth substance due to caries, fractures, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in decidious teeth, core build-ups, cavity lining, cavity floor elevation, blocking out undercuts, repair of direct restorations after appropriate pretreatment, extended fissure sealing and splinting / locking of teeth.
Visalys® Bulk Fill is a light-cured, nano-hybrid filling composite that can be modeled and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in screw syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 82% inorganic fillers by weight. The radiopacity is 2.5 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Fill is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V.
Visalys® Bulk Flow is a light-cured, flowable nano-hybrid filling composite and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 72% inorganic fillers by weight. The radiopacity is 2.0 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Flow is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V. Capping is not necessary.
The provided text focuses on the substantial equivalence of dental restorative materials (Visalys® Bulk Fill and Visalys® Bulk Flow) to a predicate device. It does not describe a device that uses AI or machine learning, nor does it detail acceptance criteria related to typical AI/ML performance metrics such as sensitivity, specificity, or AUC.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document describes traditional performance testing for dental materials, primarily focusing on physical and chemical properties and biocompatibility.
Here's an overview of the information present in the document that aligns with the context of a medical device submission, but not specifically for an AI/ML device:
1. Table of acceptance criteria and reported device performance:
The document lists performance tests conducted in accordance with various ISO standards for "Polymer-based restorative materials" (ISO 4049). It states that a "comparison of the parameters in respect to mechanical properties was performed. The results demonstrate the substantial equivalence to the predicate device." However, specific numerical acceptance criteria (e.g., "flexural strength > X MPa") and the reported numerical performance values for the subject devices are not explicitly stated in the provided text. It only mentions that the results demonstrate substantial equivalence.
| Acceptance Criteria Category | Standard Used | Reported Device Performance |
|---|---|---|
| Sensitivity to light | ISO 4049 / 7.9 | Results demonstrate substantial equivalence to the predicate device. |
| Depth of cure | ISO 4049 / 7.10 | Results demonstrate substantial equivalence to the predicate device. |
| Flexural strength | ISO 4049 / 7.11 | Results demonstrate substantial equivalence to the predicate device. |
| Elastic modulus | ISO 4049 / 7.11 | Results demonstrate substantial equivalence to the predicate device. |
| Water sorption | ISO 4049 / 7.12 | Results demonstrate substantial equivalence to the predicate device. |
| Solubility | ISO 4049 / 7.12 | Results demonstrate substantial equivalence to the predicate device. |
| Shade of restorative materials | ISO 4049 / 7.13 & ISO 7491 / ANSI ADA Spec. 80 | Results demonstrate substantial equivalence to the predicate device. |
| Color stability after irradiation and water sorption | ISO 4049 / 7.13 & ISO 7491 / ANSI ADA Spec. 80 | Results demonstrate substantial equivalence to the predicate device. |
| Radio-opacity | ISO 4049 / 7.14 & ISO 13116 | Results demonstrate substantial equivalence to the predicate device. |
| Volume shrinkage | ISO 17304 | Results demonstrate substantial equivalence to the predicate device. |
| Shear bond strength to dentin | ISO 29022 | Results demonstrate substantial equivalence to the predicate device. |
| Shear bond strength to restorative materials | ISO 29022 | Results demonstrate substantial equivalence to the predicate device. |
| Duration of light curing | Internal test method | Results demonstrate substantial equivalence to the predicate device. |
| Extrusion force (Bulk Flow only) | Internal test method | Results demonstrate substantial equivalence to the predicate device. |
| Consistency (Bulk Fill only) | Internal test method | Results demonstrate substantial equivalence to the predicate device. |
| High shear viscosity (Bulk Flow only) | Internal test method | Results demonstrate substantial equivalence to the predicate device. |
| Low shear viscosity (Bulk Flow only) | Internal test methods | Results demonstrate substantial equivalence to the predicate device. |
| Universal color | In-vitro test | Results demonstrate substantial equivalence to the predicate device. |
| Biocompatibility (Cytotoxicity, Sensitization, Genotoxicity, Toxicological risk assessment, Chemical characterization) | ISO 10993-5, ISO 10993-10, ISO 10993-3, ISO 10993-17, ISO 10993-18, ISO 7405 | Comparable to other materials on the market, no toxicological risks. |
2. Sample size used for the test set and the data provenance: Not applicable. The tests are bench tests of material properties, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by standardized physical/chemical testing, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the performance testing is based on established physical and chemical measurements defined by international ISO standards for dental materials.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.